An interventional study of 3D-Printed Palatal Crib Appliance Therapy (Group I): and Conventional Soldered Palatal Crib Appliance Therapy (Group II) in 3D Printing, Oral Habit and Patient Comfort, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 7 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This randomized controlled clinical trial evaluates and compares the clinical effectiveness of 3D-printed palatal cribs versus conventional soldered palatal cribs in managing the tongue thrusting habit in pediatric patients.
Thirty children aged 7 to 10 years presenting with a tongue thrusting habit and Class I molar relationship are randomly allocated into two equal groups (n=15 per group). Group I is treated with a 3D-printed selective laser-melted cobalt-chromium palatal crib, while Group II receives a conventional soldered stainless steel palatal crib. Treatment outcomes are evaluated over a 6-month follow-up period by assessing dentoalveolar dimensional changes (via 3D digital model analysis of overjet, overbite, intercanine width, intermolar width, and arch length), appliance survival and structural integrity (debonding, deformation, solder breakage, and loosening), gingival and plaque health indices, and patient-reported comfort and acceptance.
Tanta University is the lead sponsor of 991 studies on the registry; 316 are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Children diagnosed with a tongue thrusting habit are treated using a custom-designed 3D-printed palatal crib fabricated via selective laser melting (SLM) of cobalt-chromium alloy from digital intraoral scans.
Device: 3D-Printed Palatal Crib Appliance Therapy (Group I):
Children diagnosed with a tongue thrusting habit are treated using a conventional orthodontic palatal crib fabricated with stainless steel bands, soldered wires, and traditional alginate impression methods.
Device: Conventional Soldered Palatal Crib Appliance Therapy (Group II)
Digital Workflow: Intraoral digital scan captured and saved in STL format; appliance digitally designed using OnyxCeph software. Fabrication: Manufactured via selective laser melting (SLM) using Remanium® star cobalt-chromium powder. Cementation: Professional prophylaxis, enamel conditioning with 37% phosphoric acid, application of metal primer to the fitting surface, universal adhesive application, and luting directly to the maxillary first permanent molars using light-cure orthodontic composite resin.
Impression \& Fabrication: Stainless steel orthodontic bands fitted to maxillary first permanent molars; conventional alginate impression taken; appliance fabricated in a dental laboratory by soldering 0.9 mm stainless steel wire and an anterior crib component to the molar bands. Cementation: Orthodontic separators placed prior to delivery; appliance cemented using self-curing glass ionomer luting cement (Micron Luting) following standard cleaning and isolation.
Dentoalveolar Dimensional Changes (Dental Cast Analysis)
Measure: Changes in dental arch dimensions measured from digital models (STL files) generated from initial scans (T1) and 6-month post-treatment scans (T2) using 3D analysis software. Parameters measured include: Overjet , Overbite , Intercanine width, Intermolar width, Arch length
Time frame: Baseline (T1) and 6 months post-cementation (T2).
Appliance Cumulative Survival
Proportion of appliances remaining fully intact and functional without major failure events, expressed as a cumulative percentage.
Time frame: At 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Failure Rate
Failure is defined as the occurrence of any of the following binary clinical events (Yes/No): complete debonding, solder joint breakage, band loosening, or crib dislodgement requiring repair or remaking.
Time frame: At 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Gingival Index Score
Evaluation of marginal gingival tissue health surrounding the anchor molars using the Löe-Silness Gingival Index. Scored on a 0 to 3 scale across four surfaces per tooth (mesial, distal, buccal, lingual): 0 = Normal gingiva, no inflammation; 1. = Mild inflammation, slight erythema, no bleeding; 2. = Moderate inflammation, erythema, bleeding on probing; 3. = Severe inflammation, severe erythema/edema, tendency to spontaneous bleeding. Scores across the four surfaces are averaged.
Time frame: Baseline (pre-cementation), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
Patient Comfort and Acceptance
Measure: Evaluation of patient-reported perceptions regarding speech interference, eating difficulty, pain/discomfort, and overall satisfaction using a structured questionnaire.
Time frame: Assessed during initial adaptation and follow-up intervals over the 6-month study period.
Plaque Index Score
Evaluation of soft deposit accumulation along the gingival margin of anchor teeth using the Silness-Löe Plaque Index. Scored on a 0 to 3 scale across four surfaces per tooth (mesial, distal, buccal, lingual): 0 = No plaque; 1. = Thin film at free gingival margin visible only on probing; 2. = Moderate accumulation of soft deposits visible to naked eye; 3. = Abundance of soft matter within sulcus/pocket. Scores across the four surfaces are averaged.
Time frame: Baseline (pre-cementation), 2 weeks, 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months post-cementation.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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